Quality Engineer

Boston Scientific Gruppe; Batu Kawan; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading medical device company is seeking an experienced Quality Engineer in Batu Kawan, Malaysia. The role involves implementing process control systems, applying robust problem-solving methodologies, and ensuring compliance with quality standards. Candidates should have at least 5 years of experience in Operations Quality, preferably in the medical device sector. This position offers an opportunity to contribute to quality excellence in manufacturing.

Qualifications

• At least 5 years of experience in Operations Quality.
• Prior experience in the medical device industry is preferred.
• Experience in product transfer will be added advantage.

Responsibilities

• Identify and implement effective process control systems.
• Ensure Quality engineering methodologies meet requirements.
• Create and revise departmental procedures.
• Act as a leader in supporting quality disciplines.
• Apply systematic problem-solving methodologies.
• Develop testing and inspection methodologies.
• Review and develop validation protocols and reports.
• Interface with other engineering departments on quality issues.

Skills

Problem-solving tools

Quality operations fundamentals

Process validation

Data analysis

Education

Degree in Engineering or Science

Job description

Responsibilities

• Identify and implement effective process control systems to support the development, qualification, and on‐going manufacturing of products to meet or exceed internal and external requirements
• Ensure Quality engineering methodologies systems practices which meets BSC, customer and regulatory requirements.
• Create, and revise, departmental procedures.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Develop testing and inspection methodologies and documentation for new and existing products. Generate test protocols/reports and execute qualification and validation testing.
• Responsible for reviewing and developing validation protocols and reports. Support other functional areas during the validation activities
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues.
• Conversant with validation techniques and associated regulatory requirements

Qualifications

• Minimum Degree in Engineering or Science
• At least 5 years of experience in Operations Quality. Prior experience in the medical device industry is preferred.
• Required skills: Resolves issues using standard problem‑solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. Process validation.
• Experience in product transfer will be added advantage.

Requisition ID: 604223

Job Segment: Medical Device Engineer, Quality Engineer, Medical Device, Inspector, Manufacturing Engineer, Engineering, Healthcare, Quality